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Journal of Clinical Microbiology, February 2003, p. 667-670, Vol. 41, No. 2
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.2.667-670.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Six Rapid Tests for Direct Detection of Clostridium difficile and Its Toxins in Fecal Samples Compared with the Fibroblast Cytotoxicity Assay

David K. Turgeon,1,{dagger} Thomas J. Novicki,2,{ddagger} John Quick,1 LaDonna Carlson,1 Pat Miller,2,3 Bruce Ulness,2,{ddagger} Anne Cent,1 Rhoda Ashley,1 Ann Larson,1 Marie Coyle,1 Ajit P. Limaye,1 Brad T. Cookson,1 and Thomas R. Fritsche1*

Department of Laboratory Medicine, School of Medicine, University of Washington,1 Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington2

Received 1 April 2002/ Returned for modification 28 May 2002/ Accepted 11 November 2002

Clostridium difficile is one of the most frequent causes of nosocomial gastrointestinal disease. Risk factors include prior antibiotic therapy, bowel surgery, and the immunocompromised state. Direct fecal analysis for C. difficile toxin B by tissue culture cytotoxin B assay (CBA), while only 60 to 85% sensitive overall, is a common laboratory method. We have used 1,003 consecutive, nonduplicate fecal samples to compare six commercially available immunoassays (IA) for C. difficile detection with CBA: Prima System Clostridium difficile Tox A and VIDAS Clostridium difficile Tox A II, which detect C. difficile toxin A; Premier Cytoclone A/B and Techlab Clostridium difficile Tox A/B, which detect toxins A and B; and ImmunoCard Clostridium difficile and Triage Micro C. difficile panels, which detect toxin A and a species-specific antigen. For all tests, Triage antigen was most sensitive (89.1%; negative predictive value [NPV] = 98.7%) while ImmunoCard was most specific (99.7%; positive predictive value [PPV] = 95.0%). For toxin tests only, Prima System had the highest sensitivity (82.2%; NPV = 98.0%) while ImmunoCard had the highest specificity (99.7%; PPV = 95.0%). Hematopoietic stem cell transplant (HSCT) patients contributed 44.7% of all samples tested, and no significant differences in sensitivity or specificity were noted between HSCT and non-HSCT patients. IAs, while not as sensitive as direct fecal CBA, produce reasonable predictive values, especially when both antigen and toxin are detected. They also offer significant advantages over CBA in terms of turnaround time and ease of use.

* Corresponding author. Mailing address: Department of Laboratory Medicine, University of Washington, Room NW120, 1959 NE Pacific St., Seattle, WA 98195-7110. Phone: (206) 598-6131. Fax: (206) 598-6189. E-mail: fritsche{at}u.washington.edu.

{dagger} Present address: Department of Pathology, Madigan Army Medical Center, Tacoma, WA 98431.

{ddagger} Present address: Department of Laboratory Medicine, School of Medicine, University of Washington, Seattle, WA 98195.

§ Present address: Department of Pathology, Children's Hospital and Regional Medical Center, Seattle WA 98105.

Journal of Clinical Microbiology, February 2003, p. 667-670, Vol. 41, No. 2
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.2.667-670.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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